Infant Bacterial Therapeutics AB (publ) (“IBT”) announces that the last premature infant has now been enrolled and recruitment to the Phase 2 study is now closed.
The Phase 2 study (ClinicalTrial.gov identifier: NCT02472769), which is part of IBT´s NEC prevention development program, is a randomized, double blind, parallel-group, dose escalation placebo-controlled multicenter study performed at neonatal intensive care units in the USA. The aim of the study is to investigate the safety and tolerability of two doses of the drug candidate (IBP-9414) administered to preterm infants. One-hundred and twenty (120) premature infants with birth weights ranging from 500g to 2,000g are included in the study. All patients in the study are treated with IBP-9414 or placebo for 14 days. The study ends after the last infant has been followed up for 6 months after the last dose administered.
Staffan Strömberg, Chief Executive Officer of IBT, commented “Reaching this milestone within the expected time frame is the result of diligent work by the study investigators and our own staff. We are pleased to have reached this goal considering the urgent need for a preventive therapy against this fatal disease NEC.”
Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. Using its extensive experience in live bacterial therapeutics and its well-developed knowledge of the action of Lactobacillus reuteri, IBT is developing its lead drug candidate IBP-9414, to prevent necrotizing enterocolitis (“NEC”), a fatal, rare disease that afflicts premature infants. IBT is further pursuing a second rare disease program for the unmet medical need gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.
The FDA and the European Commission have granted IBT Orphan Drug Designation, and the FDA have granted Rare Pediatric Disease Designation for IBP-9414 for the prevention of NEC.
IBT is listed on Nasdaq First North with Erik Penser Bank as Certified Adviser.
Staffan Strömberg, CEO
Infant Bacterial Therapeutics AB
111 21 Stockholm
Phone: +46 8 410 145 55
This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16.50 CET on 24 January 2017.
See Press Release in both English and Swedish
IBT Press Release 20170124 (English)